MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXGUARD; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problem Blood Loss (2597)

Event Date 04/09/2019

Event Type  malfunction  

Event Description

Patient's drip line was changed out overnight using a bi-fuse.Around 0345, there was blood found all over the patient.Upon further investigation, the bi-fuse had come apart, causing the tubing to disconnect and blood to backup out of the open tubing onto the bed.The patient lost 80cc of blood.Labs were drawn to determine hct levels.

• Brand Name: MAXGUARD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 9653276
• MDR Text Key: 177169906
• Report Number: 9653276
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2019
• Date Report to Manufacturer: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2920 DA